Survey and Analysis of Label Items in 32 Biological Products Injection for Treatment Instructions
10.6039/j.issn.1001-0408.2016.19.40
- VernacularTitle:32份治疗用生物制品类注射剂说明书标注项的调查与分析
- Author:
Jinping HU
;
Zhihong HU
;
Chengli ZHOU
;
Huabing LI
;
Guoqin WU
- Publication Type:Journal Article
- Keywords:
Biological products for treatment;
Injection;
Instructions;
Marked items
- From:
China Pharmacy
2016;27(19):2722-2725
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide reference for the further standardization of biological products injection for treatment in-structions. METHODS:32 biological products injection for treatment instructions collected from Ma’anshan Center for Disease Control and Prevention and Ma’anshan Central Hospital during Jan. to Jun. in 2015. The information of marked item was summa-rized and analyzed. RESULTS & CONCLUSIONS:Among 32 biological products injection for treatment instructions, the mark rates of drug names,main ingredients,character,indications,specification,usage and dosage,package,term of validity,opera-tive norm,license number,manufacturing enterprise and other items all reached 100%. Although the mark rates of ADR,contrain-dication,precaution,drug use of pregnant women and nursing mothers,drug interactions,pharmacokinetics,drug use of the elder-ly,storage and other items were relatively high,but some items lacked the specific description of the content. The mark rates of drug use of children,drug overdose,toxicology,warnings,clinical trial were 56.25%,62.50%,59.38%,37.50% and 18.75%. Some biological products injection for treatment instructions are not revised timely and not complete in content and non-standard in writing,which can not meet the needs that clinical pharmacists and patients get enough drug safety information from instructions. Manufacturing enterprise is suggested to label the content of package inserts completely,verify and supplement related content, standardize and improve the instructions.
